Japanese health officials restricted the distribution of Moderna’s COVID-19 vaccine after a pharmacist reported a black substance in a vial – now identified as stainless steel, likely added to the vial due to a manufacturing defect.
This is Moderna’s second suspension in a week – Japan previously stopped distributing 1.63 million doses over contamination concerns.
About 3,790 people were vaccinated from this. Two Japanese died recently after being vaccinated, but health officials say the deaths have nothing to do with vaccine contamination.
The vaccine suspension is bad news as Japan experiences another Covid wave after the Tokyo Olympics. Less than half of the country’s population is fully vaccinated against Covid.
Japan has blocked use of Moderna’s Covid vaccine for the second time in a week. Pictured: Moderna vials, pictured at a mass vaccination site in Lynchburg, Virginia, March 2021
Japan has blocked the use of Moderna’s Covid vaccine for the second time this week over contamination concerns.
On August 26, the country discontinued use of 1.63 million Moderna doses, when Takeda, the Japanese company that distributes vaccines, reported contamination.
The vials were bottled by Rovi, a Spanish pharmaceutical company that partnered with Moderna to manufacture vaccines for recipients outside the US.
Moderna and Rovi both suspect a manufacturing defect caused the contamination.
The new case of infection, announced Wednesday, is the fourth incident reported in the past week.
This report came from a pharmacist in Kanagawa Prefecture, a coastal area on the eastern border of the country.
This pharmacist found ‘black particles’ in one vaccine vial when double checking the Moderna vaccines for external substances – as all medical personnel must do before a dose is given.
Kanagawa leaders immediately put the rest of the Moderna vaccines from that batch on hold.
Takeda, the domestic distribution company, has collected the bottle containing ‘black particles’ for examination.
Moderna and Takeda say the “black particles” are stainless steel particles, likely added as a result of a manufacturing error that occurred when machines added rubber stoppers to the vials, according to Reuters and Japan Today.
Japan is currently seeing more than 20,000 new Covid cases per day in the country’s highest-ever rise
“The rare presence of stainless steel particles in the Moderna COVID-19 vaccine does not pose an undue risk to patient safety and does not adversely affect the benefit-risk profile of the product,” Moderna and Takeda said in a joint statement:.
“Stainless steel is routinely used in heart valves, joint replacements and metal sutures and staples,” the two companies said.
“As such, injection of the particles identified in these batches in Japan is not expected to lead to an increased medical risk.”
About 3,790 people had received injections of the Kanagawa batch before the vaccines were suspended.
Although two vaccinated individuals have recently died, existing evidence does not link these deaths to vaccine contamination.
However, Moderna and Japanese health officials continue to investigate the situation.
About 58 percent of Japanese residents received at least one vaccine dose on September 1.
The European Medicines Agency (EMA) is also investigating contamination issues in Japan, as they may affect the distribution of vaccines in the European Union.
When announcing the August 26 suspension, Japanese health officials called it a precautionary measure, with no specific safety concerns identified.
But this suspension still caused some Japanese companies to cancel planned employee vaccination events, Reuters reported.
This is a worrying signal, as Japan’s cases remain high after the Tokyo Olympics and the takeover of the Indian ‘Delta’ variant.
The country is currently seeing more than 20,000 new cases per day – equivalent to about 16 new cases per day for every 100,000 inhabitants.
It is the highest increase Japan has seen to date during the pandemic.
Japan’s vaccination campaign was slow and hampered by bureaucratic problems, leaving them behind the vaccination efforts of other high-income countries.
By September 1, about 58 percent of Japanese residents have received at least one dose and 47 percent are fully vaccinated.